Recall Atlas

Intersect ENT recalls

2 official recalls and safety alerts involving Intersect ENT since 2022-12, from FDA · Device, FDA · Drug. Newest first. Check the official notice for exact models and batch codes.

This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Intersect ENT or the relevant agency.

  1. 2023-01-25
  2. US
    Drugs & medicalClass III

    Intersect ENT, Inc. recalls SINUVA (mometasone furoate) sinus implant, 1350 mcg, 1 implant per pouch, Rx Only, intersect ENT, 1555 Adams Drive, Menlo Park, CA 94025,…

    Failed Dissolution Specification; product did not meet the average 24-hour drug release rate (dissolution) specification stability time point at 9 months.

    FDA · DrugIntersect ENT, Inc.NationwideOfficial notice →
  3. 2022-12-14
  4. US
    Drugs & medicalClass II

    Intersect ENT, Inc. recalls Propel Mini Mometasone Furoate Sinus Implant, with Straight Delivery System, REF 60044

    Sinus Implant product label displays incorrect product information including: "Straight Delivery System", with incorrect reference number and UDI-DI.

    FDA · DeviceIntersect ENT, Inc.US Nationwide distribution including in the states of NC, IL, KS, OR, WI, TX,…Official notice →